As part of Nutraceuticals World’s 2026 State of the Industry review, Ivan Wasserman, Managing Partner at Amin Wasserman Gurnani, examines the shifting regulatory landscape facing the supplement industry. He anticipates new federal rules on GRAS notifications, increased state activity, and potential resurgence in enforcement from the FTC and state attorneys general — all against a backdrop of political uncertainty and evolving oversight priorities.

On the regulatory front, the next 12 months are sure to see a continued flurry of activities at the states, including warning labels for certain ingredients, like Texas and Louisiana.

At the federal level we will almost certainly see an FDA-proposed rule that will likely require manufacturers to submit GRAS notices for new food ingredients, including those in packaging, before they can be used. It would eliminate the current “self-affirmed” GRAS pathway, where companies can determine that an ingredient is safe without notifying the FDA. Exemptions will likely apply to substances already listed as GRAS or for which the FDA has issued a “no questions letter.”

The unknowns are plentiful, including the timing of the proposal and final rule (if ever), the compliance dates, how FDA will possibly handle the additional work without additional funding and employees qualified to do that type of scientific review (AI??), legal challenges (bills have also been introduced in Congress from both parties on this), and importantly for the industry, if it will impact the exemption from the New Dietary Ingredient Notification requirement for ingredients that are, or were, in the food supply. 

I am also somewhat anticipating a re-awakening, if you will, of the Federal Trade Commission, which has been relatively quiet in recent years with respect to enforcement against deceptive claims for supplements. The FTC is not under HHS (RFK Jr), and I could see it being encouraged to make examples of some “bad actors” to counteract any public perception that the administration is too “cozy” with supplement companies. I expect to see enforcement by State Attorneys General as well.   

Finally, will RFK, Jr. still be HHS Secretary 12 months from now? In the President’s first term, his first HHS Secretary Tom Price served a little over seven months, and midterms are often a time that Cabinet members “decide to” resign.